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AUNT KS- oatmeal, colloidal powderAUNT KS- oatmeal colloidal powderAUNT KS- oatmeal, collodial powder


  1. Otc- Active Ingredients Section
  2. Sto Use And See A Doctor If:
  3. Otc- Warnings Section
  4. Other Information
  5. Otc- Purpose Section
  6. Inactive Ingredients
  7. Keep Out Of Reach
  8. Dosage Section
  9. Indications And Usage
  10. Package Label

Otc- Active Ingredients Section 

Organic Colloidal Oatmeal 1.25%..... Skin Protectant

Sto Use And See A Doctor If: 

Conditions worsen

Symptoms last more than 7 days

Symptoms clear up and reoccur within a few days.

Otc- Warnings Section 

For external use only

when using this product: Keep away from face to avoid inhalation

Avoid contact with eyes

Do not use on wet hair, or allow to dry on wet hair

Other Information 

Store in a dry place

protect from moisture

Otc- Purpose Section 

Uses: Helps treat and prevent diaper rash

Temporarily protects and helps relieve minor skin irritation and itching due to diaper rash.

Inactive Ingredients 

Powdered White Soft Wheat

Keep Out Of Reach 

Keep out of reach of Children

Dosage Section 

Apply as Needed

Use Generous amounts for best results

Indications And Usage 

Uses: Helps treat and prevent diaper rash

Package Label 

Comfy Bottoms Baby PowerComfy Bottoms Sports PowderComfy Bottoms Foot Powder

AUNT KS
oatmeal, colloidal powder
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:23264-200
Route of Administration TOPICAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL 1.25 g in 100 g
Inactive Ingredients
Ingredient Name Strength
WHEAT (UNII: 4J2I0SN84Y)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:23264-200-03 113 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/14/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 11/14/2014
AUNT KS
oatmeal colloidal powder
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:23264-300
Route of Administration TOPICAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL 1.25 g in 100 g
Inactive Ingredients
Ingredient Name Strength
WHEAT (UNII: 4J2I0SN84Y)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:23264-300-03 113 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/14/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 11/14/2014
AUNT KS
oatmeal, collodial powder
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:23264-100
Route of Administration TOPICAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL 1.25 g in 100 g
Inactive Ingredients
Ingredient Name Strength
WHEAT (UNII: 4J2I0SN84Y)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:23264-100-03 113 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/14/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 11/10/2014
Labeler - Comfy Bottoms, LLC (047137184)
Registrant - Comfy Bottoms, LLC (047137184)
Establishment
Name Address ID/FEI Business Operations
CTL Foods 133541248 manufacture(23264-200, 23264-100, 23264-300)

Revised: 12/2016 Comfy Bottoms, LLC



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